Last week, the United States Court of Appeals for the Federal Circuit issued an opinion in Amgen Inc. v. Sandoz Inc., No. 2018-1551 (May 8, 2019), holding Sandoz’s biosimilar versions of Amgen’s Neupogen® and Neulasta® drugs do not infringe Amgen’s patents. The decision affirmed the district court’s grant of summary judgment of nonfringement in a case brought under the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”), 42 U.S.C. § 262 (2012), enacted as part of the Patient Protection and Affordable Care Act.
Filgrastim and pegfilgrastim, marketed by Amgen as Neupogen® and Neulasta®, are drugs used to treat cancer patients affected by neutropenia, a deficiency of white blood cells often resulting from chemotherapy or radiotherapy. Amgen’s process for making the drugs is protected by U.S. Patent Nos. 8,940,878 and 6,162,427. In 2014, Sandoz submitted to the Food and Drug Administration an abbreviated Biologics License Application (“aBLA”) to market its biosimilar filgrastim product, Zarxio®. In 2015, it submitted an aBLA to market a biosimilar pegfilgrastim product. Amgen sued after each aBLA filing, alleging Sandoz’s processes infringed its patents. Zarxio® became the first biosimilar approved under the BPCIA.
The ’878 patent discloses a method of protein purification. The district court construed the limitations of claim 7 as separate steps that must occur in sequence. Its construction was dispositive, for it was “undisputed that Sandoz’s process only involves one step.” The Federal Circuit affirmed. It rejected Amgen’s argument that the limitations of claim 7 described functions, not process steps, based on the claim language and specification’s description of the steps. The Court also rejected Amgen’s doctrine of equivalents argument, holding that “Sandoz’s one-step, one-solution process does not function in the same way as the claimed process” but instead “works in a substantially different way from the claimed three-step, three-solution process.”
The ’427 patent discloses “methods of treating ‘diseases requiring peripheral stem cell transplantation.’” The district court construed the limitation “disease treating-effective amount” as “[a]n amount sufficient to treat a disease for which at least one chemotherapeutic agent is prescribed.” The Federal Circuit affirmed. It rejected Amgen’s argument that the limitation covers situations in which the chemotherapeutic agent is prescribed only for “stem cell mobilization rather than treatment of an underlying disease,” finding the agent “must be administered to treat the underlying disease.”